Polycythemia Vera Market

DelveInsight's "Polycythemia Vera (PV)- Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the PV, historical and forecasted epidemiology as well as the PV market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

 

The PV market report provides current treatment practices, emerging drugs, PV market share of the individual therapies, current and forecasted PV market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current PV treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019-2032

Polycythemia Vera (PV) Disease Understanding and Treatment Algorithm

Polycythemia Vera, or PV, is a rare blood disease in which the body makes excessive red blood cells. The extra red blood cells make the blood thicker than normal. As a result, blood clots can form more easily, and these clots can block blood flow through arteries and veins, which can cause a heart attack or stroke. Thicker blood also does not flow as quickly in the body as normal blood. Also, slowed blood flow prevents the organs from getting enough oxygen, which can cause serious problems, such as angina and heart failure.

 

In the early stages, there are not any specific signs and symptoms. When too many RBCs and platelets build up in the blood, symptoms start to appear, which may cause a problem. The symptoms are not noticeable due to an increased number of cell count, but can predict a higher risk of clot formation. Headache, dizziness, fatigue, blurred vision or blind spots, shortness of breath, itchy skin, spleen enlargement (Splenomegaly) blood clot, heavy bleeding, and others are the symptoms of PV.

 

PV is usually diagnosed in the average age of people 60–65 years. It is uncommon in people under the age of 40. PV develops more often in men than in women. Most people with PV do not have a family history of this disease. Mutation in the JAK2 kinase is responsible for PV. Most cases of PV are associated with genetic changes that are somatic, not in the egg and sperm cells, which pass on genetic information to offspring.

 

Enlargement of the spleen sometimes cause pain and problem to the patients, and for that surgery is done to remove the spleen (Splenectomy). No single treatment has been found to be effective for all individuals. The prognosis of PV largely depends on whether a patient receives treatment or not.  Treatment helps reduce the risk of life-threatening complications like myelofibrosis, heart attack, ischemic stroke, pulmonary embolism, portal hypertension, acute myeloid leukemia (AML). These complications from PV are possible even with treatment, but the risk is much lower.

 

Diagnosis

The diagnosis of PV vastly grew after understanding the pathogenesis activating mutations in the Janus kinase 2 (JAK2) gene, which was identified in most patients with PV, with the classical JAK2 V617F mutation. PV diagnosis is currently based on the 2008 World Health Organization (WHO) diagnostic criteria.

 

The WHO diagnostic criteria emphasize laboratory values, morphologic features, and genetic data, with erythrocytosis being the first major criterion. During the diagnosis high RBC count, mass, hemoglobin, hematocrit WBC, platelet count, and other diagnostic abnormalities, etc. are looked for.

 

Treatment

The goals of treating PV are to control symptoms and reduce the risk of complications, especially heart attack and stroke. In order to do this, PV treatments reduce the number of red blood cells and the level of hemoglobin (an iron-rich protein) in the blood; this brings the thickness of the blood closer to normal.

 

Many individuals with PV receive treatment with certain drugs (myelosuppressive drugs) that suppress the formation of blood cells by the marrow. A chemotherapy drug known as Hydroxyurea is most often used, along with another chemotherapy drug known as busulfan. Other drugs, such as chlorambucil and radioactive phosphorous, have been used in the past. Still, these drugs, especially in individuals requiring long-term therapy, have been associated with an increased risk of developing leukemia. Till now, two drugs have been approved for the PV, i.e., Jakafi (Ruxolitinib) and Besremi (ropeginterferon alfa-2B/AOP2014/P1101).

Polycythemia Vera (PV) Epidemiology

The PV epidemiology division provides insights about historical and current PV patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

 

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted PV epidemiology [segmented as total prevalent cases of PV, prevalence based on symptom cases of PV, age-specific cases of PV, gender-specific cases of PV, risk-specific cases of PV and mutation-specific cases of PV in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise Polycythemia Vera (PV) Epidemiology

  • Estimates show that the highest cases of PV in the 7MM were in the United States, followed by Japan, Germany, France, the United Kingdom, Italy, and Spain in the year 2021.
  • The total prevalent population of PV in the 7MM was 298,160 cases in 2021. The cases in the 7MM are expected to increase during the study period, i.e., 2019–2032.
  • The total population of 169,322 cases was estimated in the US for PV in 2021, out of which 67,729 cases and 101,593 cases were contributed by asymptomatic and symptomatic, respectively.
  • The United States accounted for 685; 1,618; 4,822; 10,064; 28,432 and 55,972 cases for the age group 0-34 years, 35-44 years, 45-54 years, 55-64 years, 65-74 years and 75+ years in 2021.
  • In the United States, there were 65,731 males and 35,862 females with PV in 2021. These cases are likely to increase during the study period.
  • A total of 101,593 prevalent population (symptomatic) of PV was assessed in 2021. Out of these cases, 94,604 cases of PV were calculated for patients with JAK2 V617F, thereby accounting for the highest number of cases with gene mutation. In contrast, the lowest number of cases was observed for patients with JAK2 exon 12, which was assessed to be equivalent to 2,926 cases in 2021. On the other hand, the symptomatic prevalent population of patients with other gene mutations was calculated to be 4,064 in 2021.
  • The epidemiology model of DelveInsight’s suggests that around 91,434 patients accounted in low-risk category, and 10,159 patients accounted for high-risk category in 2021 in the United States.
  • Among the EU-5 countries in 2021, Germany had the highest prevalent population of PV patients with 24,380 cases, followed by France (20,602), UK (20,114) and Italy (18,994). In contrast, Spain had the lowest cases (12,756) in 2021.
  • As per DelveInsight estimates, Japan accounted for 31,992 prevalent PV cases in 2021.

Polycythemia Vera (PV) Drug Chapters

Drug chapter segment of the PV report encloses the detailed analysis of PV marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the PV clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

 

Marketed Drugs

 

Jakafi (Incyte Corporation and Novartis)

Jakafi is developed by Incyte Corporationand and Novartis, designated for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis, post-polycythemia vera (PV) myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. This drug is also approved for adult patients of PV who have had a poor response to hydroxyurea. It is a kinase inhibitor that specifically inhibits JAK1 and JAK2, which mediate the signaling of several cytokines and growth factors that are important for hematopoiesis and immune function.

 

Besremi (AOP Orphan Pharmaceuticals and PharmaEssentia)

Besremi (ropeginterferon alfa-2B/AOP2014/P1101) is mono-pegylated proline interferon approved as first-line monotherapy in adults for the treatment of polycythemia vera (PV) without symptomatic splenomegaly. It is one of the first of its kind to be approved for the condition. It is a long-acting, mono-pegylated proline interferon developed using PharmaEssentia’s novel pegylation technology platform. The drug has exhibited improved pharmacokinetic properties in clinical studies, including increased tolerability and convenience. Besremi is designed to be self-administered subcutaneously with a pen once every 2 weeks or monthly during long-term maintenance. This treatment schedule is expected to improve overall safety, tolerability, and adherence compared to conventional pegylated interferons.

 

In November 2021, Besremi was approved by FDA (ropeginterferon alfa-2b-njft) for the treatment of adults with PV, the first interferon approved for PV worldwide and the only approved first-line treatment for PV in the US. Besremi became commercially available in the US in December 2021. In addition, Besremi is disclosed to be in regulatory review in Japan.

Note: Detailed Current therapies assessment will be provided in the full report of PV

 

Polycythemia Vera (PV) Emerging Drugs

Drug chapter segment of the PV report encloses the detailed analysis of PV marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the PV clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

 

Rusfertide (Protagonist Therapeutics)

Rusfertide (PTG-300) is an injectable compound that mimics the effect of the natural hormone hepcidin but with greater potency, solubility, and stability. As a hepcidin mimetic, PTG-300 may redistribute iron to the macrophages, reduce iron-induced oxidative stress in the bone marrow, and allow sufficient production of red blood cells. Protagonist Therapeutics is currently developing PTG-300 for hereditary hemochromatosis, elevated hematocrit, and myelodysplastic syndromes. In December 2021, the company announced updated Phase II data, evaluating rusfertide in patients with PV, demonstrating its ability to eliminate the need for phlebotomies in patients essentially.

 

Givinostat (Italfarmaco)

Givinostat (ITF2357) is an orally bioavailable hydroxymate inhibitor of histone deacetylase (HDAC) with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities. Givinostat inhibits class I and class II HDACs, resulting in an accumulation of highly acetylated histones, followed by the induction of chromatin remodeling and an altered pattern of gene expression. Givinostat is thought to work by reducing the levels of JAK2. In patients with polycythemia, the reduction of mutant JAK2 concentrations by givinostat is believed to slow down the abnormal growth of erythrocytes and ameliorate the symptoms of the disease. The company is investigating givinostat in Phase II clinical trials in patients with PV. Italfarmaco expects to initiate the global Phase III trial with givinostat in PV patients by mid-2021, with more than 100 participating sites in Europe, US, Canada, and Asia.

 

KRT-232 (Kartos Therapeutics)

KRT-232 is an orally administered, small-molecule inhibitor of MDM2, being developed by Kartos Therapeutics to treat PV, Merkel cell carcinoma, and myelofibrosis, including primary myelofibrosis, post PV myelofibrosis, and post essential thrombocythemia myelofibrosis. The MDM2-p53 interaction represents a compelling therapeutic target with the potential to provide a new treatment option for patients with Myelofibrosis (MF), PV, Acute Myeloid Leukemia (AML), and Merkel Cell Carcinoma (MCC). The company is investigating the molecule in Phase II clinical trial for the treatment of patients with phlebotomy-dependent PV.

 

Bomedemstat (Imago BioSciences)

Bomedemstat (IMG-7289) is an orally bioavailable small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A)—an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. LSD1 inhibition modulates the proliferation of malignant blood cells and therefore represents a viable therapeutic approach to treating PV, an MPN characterized by the excessive production of red blood cells. In December 2021, the company announced positive data from its ongoing global Phase II clinical study evaluating bomedemstat in patients with essential thrombocythemia (ET).

 

Itacitinib (Incyte)

Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD and PV. In July 2021, Incyte initiated a 2-Part, Phase II, open-label study of the safety, tolerability, and efficacy of Itacitinib immediate release in participants with primary myelofibrosis or secondary myelofibrosis (Post-PV myelofibrosis or post-essential thrombocythemia myelofibrosis) who have received prior ruxolitinib and/or fedratinib monotherapy. The trial is expected to be completed by July 2025, with an estimated enrollment of 73 participants.

 

Other products in development include Sapablursen (IONIS-TMPRSS6-LRx) by Ionis Pharmaceutical and PPMX-T003 by Perseus Proteomics.

Note: Detailed emerging therapies assessment will be provided in the final report.

Polycythemia Vera (PV) Market Outlook

Patients with Polycythemia Vera (PV), a myeloproliferative neoplasm characterized by an elevated red blood cell mass, are at high-risk of vascular and thrombotic complications and have reduced quality of life due to a substantial symptom burden that includes pruritus, fatigue, constitutional symptoms, microvascular disturbances, and bleeding. Conventional therapeutic options aim at reducing vascular and thrombotic risk, with low-dose aspirin and phlebotomy as first-line recommendations for patients at low risk of thrombotic events and cytoreductive therapy (usually hydroxyurea or interferon alpha) recommended for high-risk patients.

 

Cytoreductive therapies have been used in older patients and those with a history of thrombosis to achieve these goals. Hydroxyurea (HU) remains the first line cytoreductive choice; however, up to one in four patients treated with HU over time will develop resistance or intolerance to HU and go for the second line therapy. More importantly, patients who fail HU have a 5.6-fold increase in mortality and a 6.8-fold increased risk of transformation to myelofibrosis or AML; therefore, alternative therapies are needed for these patients. Interferon-α has been used in PV and has shown significant activity in achieving hematologic responses and decreasing JAK2 V617F mutation allele burden. JAK inhibition has also been investigated and recently garnered regulatory approval for this indication.

 

The goals of PV treatment highlight the need to reduce the risk of cardiovascular events and TEs and to alleviate disease-related symptoms. Treatment with aspirin and maintenance of hematocrit level <45% with phlebotomy are associated with reduced risk of cardiovascular events, TEs, and related deaths. Some patients benefit from the addition of cytoreductive therapy, which is often HU; however, resistance and intolerance to HU have been documented in a significant proportion of patients with PV treated with HU, respectively.

 

At present, the therapeutic landscape of PV in the US and EU-5 countries is not just dependent on supportive treatment regimens but is also attributed to two of the approved therapies, namely Besremi (AOP Orphan Pharmaceuticals AG/PharmaEssentia) and Jakafi (ruxolitinib; Incyte Corporation/Novartis). In Japan, available cytoreductive medications include hydroxyurea, interferon alfa (IFN-α), and busulphan. Only approved therapy is ruxolitinib and besremi is under regulatory review in Japan.

 

The PV pipeline possesses drugs in the late-stage development, many of which hold the potential to get launched in the forecast period. The key players involved in the development of targeted therapies for the treatment of PV include Protagonist Therapeutics (Rusfertide), Italfarmaco (Givinostat), Kartos (KRT-232), Imago BioSciences (Bomedemstat), Ionis Pharmaceutical (Sapablursen), Incyte (Itacitinib) and others investigating their candidates for the treatment of PV in the 7MM.

 

According to DelveInsight, PV market in 7MM is expected to witness a major change in the study period 2019-2032.

 

Key Findings

  • The market size of PV in the seven major markets is expected to rise from USD 1,531.4 million in 2021 during the study period (2019–2032).
  • The United States accounts for the largest market size of PV compared to EU5 (Germany, France, Italy, the United Kingdom, and Spain) and Japan.
  • In the United States, the market size of PV is anticipated to rise from USD 1,083.1 million in 2021 during the forecast period.
  • Among the EU5 countries, Germany had the largest market size (USD 84.8 million) in 2021, while Spain had the smallest with USD 44.4 million.
  • In 2021, Japan accounted for a market size of USD 125.5 million.

 

The United States Market Outlook

The total market size of PV in the United States is expected to increase with a CAGR of 16.36% in the study period (2019–2032).

 

EU-5 Countries: Market Outlook

The total market size of PV in EU5 is expected to increase with a CAGR of 10.8% in the study period (2019–2032).

 

Japan Market Outlook

The total market size of PV in Japan is expected to increase with a CAGR of 7.04% in the study period (2019–2032).

Analyst Commentary

  • The market size of PV is expected to witness significant competition, wherein Jakafi is likely to maintain dominance in the hydroxyurea-refractory (second line) PV market for sometime, however we expect a decline in patient share once several second line therapies enter the market.
  • Moreover, Jakafi is also expected to witness market erosion in 2028 once its generics make an entry.  Additionally, Jakafi has been dominant in the myelofibrosis (MF) and PV markets since FDA approval in 2011 and 2014, respectively. With Jakafi now on the market for over seven years, minor signs of market maturation have been observed with slowing growth. No serious threats to Jakafi dominance have been witnessed in the near future due to lack of competition, long patent life (up to 2027, with potential for extensions), and what remains a high unmet need in both indications.
  • On the other hand, Besremi is expected to give stiff competition to hydroxyurea as well as Jakafi (in younger patients where Jakafi is either unsafe or intolerant) as Besremi is expected to make a place for itself in both first and second line treatment for PV. Infact, Delveinsight believes that Besremi will possibly expand its niche by entering the third line of treatment in PV by targeting Jakafi intolerant patients. Besides Besremi, we also expect Itacitinib to target Jakafi intolerant patients.

Polycythemia Vera (PV) Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the PV market or expected to get launched in the market during the study period 2019-2032. The analysis covers PV market uptake by drugs; patient uptake by therapies; and sales of each drug. For example-

 

Protagonist Therapeutics is currently developing Rusfertide (PTG-300) for hereditary hemochromatosis, elevated hematocrit, and myelodysplastic syndromes. The company has announced initial Phase II results of PTG-300 in the treatment of PV. The FDA has granted orphan drug, fast track and breakthrough designation for rusfertide for the treatment of PV. EMA has also granted orphan drug designation for rusfertide for PV treatment in October 2020. In December 2021, the company announced updated Phase II data, evaluating rusfertide in patients with PV, demonstrating its ability to eliminate the need for phlebotomies in patients essentially. The current results indicate that rusfertide is an effective agent for the treatment of PV, reversing iron deficiency and eliminating the need for TP in PV patients. The drug is expected to first launch in USA (2024) followed by EU5 (2025) and Japan (2025). As per our analysis, Rusfertide’s drug uptake in 7MM is expected to be fast and an estimated 6 years to peak.

Note: Detailed emerging therapies assessment will be provided in the final report.

Polycythemia Vera (PV) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses PV key players involved in developing targeted therapeutics.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for PV emerging therapies.

Reimbursement Scenario in Polycythemia Vera (PV)

Incyte offers three financial assistance programs for patients who are using Jakafi including IncyteCARES Copay/Coinsurance Assistance Program, Connecting to Access, Reimbursement, Education, and Support and Patient Assistance Program. In IncyteCARES Copay/Coinsurance Assistance Program the patients with commercial or private insurance eligible to receive Jakafi pay only USD 25 monthly. IncyteCARES (Connecting to Access, Reimbursement, Education, and Support) program provides a single point of contact through a registered nurse to assist eligible patients and healthcare providers in obtaining access to Jakafi. The IncyteCARES Patient Assistance Program (PAP) helps eligible patients who do not have prescription drug insurance or have trouble affording their copay for Jakafi. No purchase contingencies or other obligations apply. Patients without prescription drug coverage for Jakafi, or those whose insurance has denied claims, may be eligible to receive the drug free of charge through this program.

 

Cigna, a global health service company that offered health, pharmacy, dental, supplemental insurance, and Medicare plans to individuals, families, and businesses, in January 2012, covered Peginterferon Alfa-2a (Pegasys) for treatment of PV and Essential Thrombocythemia (ET). The change in Cigna’s coverage policy resulted from a request by the MPN Research Foundation to amend its policy on Pegasys in light of the clinical trials showing the significant effectiveness in PV and ET patients. 

KOL- Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are MD at MD Anderson Cancer Center in Houston, Director of Clinical Innovation at Biologics, Hematologist, Yokohama-MInami kyousai Hospital and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PV market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the PV Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The report covers the descriptive overview of PV, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
  • Comprehensive insight has been provided into the PV epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for PV are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
  • A detailed review of PV market; historical and forecasted is included in the report, covering drug outreach in the 7MM
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global PV market

Report Highlights

  • In the coming years, PV market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
  • The companies and academics are working to assess challenges and seek opportunities that could influence PV R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition     
  • Major players are involved in developing therapies for PV. Launch of emerging therapies will significantly impact the PV market
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for PV
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Polycythemia Vera (PV)  Report Insights

  • Patient Population
  • Therapeutic Approaches
  • PV Pipeline Analysis
  • PV Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

PV Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • PV Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

PV Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers

Key Questions

Market Insights:

  • What was the PV drug class share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the PV total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
  • What are the key findings pertaining to the market across 7MM and which country will have the largest PV market size during the forecast period (2019-2032)?
  • At what CAGR, the PV market is expected to grow in 7MM during the forecast period (2019-2032)?
  • What would be the PV market outlook across the 7MM during the forecast period (2019-2032)?
  • What would be the PV market growth till 2032, and what will be the resultant market Size in the year 2032?
  • How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

  • What is the disease risk, burden and regional/ethnic differences of the PV?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical PV patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of PV in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to PV?
  • Out of all PV countries, which country would have the highest prevalent population of PV during the forecast period (2019-2032)?
  • At what CAGR the patient population is expected to grow in 7MM during the forecast period (2019-2032)?

 

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

  • What are the current options for the PV treatment in addition to the approved therapies?
  • What are the current treatment guidelines for the treatment of PV in the USA, Europe, and Japan?
  • What are the PV marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
  • How many companies are developing therapies for the treatment of PV?
  • How many therapies are in-development by each company for PV treatment?
  • How many are emerging therapies in mid-stage, and late stage of development for PV treatment?
  • What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the PV therapies?
  • What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for PV and their status?
  • What are the current challenges faced in drug development?
  • What are the key designations that have been granted for the emerging therapies for PV?
  • What are the global historical and forecasted market of PV?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the PV market
  • To understand the future market competition in the PV market and Insightful review of the key market drivers and barriers
  • Organize sales and marketing efforts by identifying the best opportunities for PV in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for PV market
  • To understand the future market competition in the PV marke

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. SWOT Analysis

6. Polycythemia Vera (PV) Market Overview at a Glance

6.1. Market Share (%) Distribution by Therapies in 2021

6.2. Market Share (%) Distribution by Therapies in 2032

7. Disease Background and Overview

7.1. Introduction

7.2. Polycythemia Vera: A Type of MPN

7.3. Signs and Symptoms of Polycythemia Vera

7.4. Causes of Polycythemia Vera

7.5. Complications due to Polycythemia Vera

7.6. Clinical Aspects of Polycythemia Vera

7.7. Pathophysiology of Polycythemia Vera

7.7.1. JAK2 V617F in Polycythemia Vera

7.8. Diagnosis of Polycythemia Vera

8. Diagnostic Guidelines

8.1. British Society for Hematology Guidelines for Polycythemia Vera 2018

8.2. WHO Diagnostic Guidelines for Polycythemia Vera, 2018

9. Treatment Algorithm, Current Treatment, and Medical Practices

9.1. Treatment Algorithm

10. Treatment Guidelines

10.1. European Society for Medical Oncology Guidelines for Polycythemia Vera, 2015

10.2. British Society for Hematology Guidelines for Polycythemia Vera, 2018

10.3. National Comprehensive Cancer Network Clinical Practice Guidelines for Polycythemia Vera, 2021

11. Epidemiology and Patient Population of 7MM

11.1. Key Findings

11.2. Epidemiology Methodology

11.3. Total Prevalent Population of Polycythemia Vera in the 7MM

11.4. Assumptions and Rationale

11.4.1. United States

11.4.2. EU5

11.4.3. Japan

11.5. The United States

11.5.1. Total Prevalent Population of Polycythemia Vera in the United States

11.5.2. Prevalent Population of Polycythemia Vera Based on Symptoms in the United States

11.5.3. Gender-specific Prevalence of Polycythemia Vera in the United States

11.5.4. Prevalence of Polycythemia Vera by Gene Mutation in the United States

11.5.5. Prevalence of Polycythemia Vera Based on Risk in the US

11.5.6. Age-specific Prevalence of Polycythemia Vera in the United States

11.6. EU5

11.6.1. Total Prevalent Population of Polycythemia Vera in EU5

11.6.2. Prevalent Population of Polycythemia Vera Based on Symptoms in EU5

11.6.3. Gender-specific Prevalence of Polycythemia Vera in EU5

11.6.4. Prevalence of Polycythemia Vera by Gene Mutation in EU5

11.6.5. Prevalence of Polycythemia Vera Based on Risk in EU5

11.6.6. Age-specific Prevalence of Polycythemia Vera in EU5

11.7. Japan

11.7.1. Total Prevalent Population of Polycythemia Vera in Japan

11.7.2. Prevalent Population of Polycythemia Vera Based on Symptoms in Japan

11.7.3. Gender-specific Prevalence of Polycythemia Vera in Japan

11.7.4. Prevalence of PV by Gene Mutation in Japan

11.7.5. Prevalence of Polycythemia Vera Based on Risk in Japan

11.7.6. Age-specific Prevalence of Polycythemia Vera in Japan

12. Patient Journey

13. Marketed Drugs

13.1. Key Competitor

13.2. Jakafi (Ruxolitinib): Incyte Corporation/Novartis

13.2.1. Drug description

13.2.2. Regulatory milestones

13.2.3. Clinical development

13.2.4. Safety and Efficacy

13.3. Besremi: AOP Orphan Pharmaceuticals and PharmaEssentia

13.3.1. Drug description

13.3.2. Regulatory milestones

13.3.3. Clinical development

13.3.4. Safety and Efficacy

14. Emerging Drugs

14.1. Key Competitors

14.2. Rusfertide (PTG-300): Protagonist Therapeutics

14.2.1. Drug Description

14.2.2. Other development activities

14.2.3. Clinical development

14.2.4. Safety and Efficacy

14.3. Givinostat (ITF-2357): Italfarmaco

14.3.1. Drug description

14.3.2. Other development activities

14.3.3. Clinical development

14.3.4. Safety and Efficacy

14.4. KRT-232: Kartos Therapeutics

14.4.1. Drug description

14.4.2. Clinical development

14.5. Bomedemstat (IMG-7289): Imago BioSciences

14.5.1. Drug description

14.5.2. Other development activities

14.5.3. Clinical development

14.5.4. Safety and Efficacy

14.6. Sapablursen (IONIS-TMPRSS6-LRx): Ionis Pharmaceutical

14.6.1. Drug description

14.6.2. Clinical development

14.7. Itacitinib: Incyte

14.7.1. Product description

14.7.2. Clinical development

14.8. PPMX-T003: Perseus Proteomics

14.8.1. Product description

14.8.2. Clinical development

15. Polycythemia Vera (PV): 7MM Market Analysis

15.1. Key Findings

15.2. Market Methodology

15.3. Total Market Size of Polycythemia Vera in the 7MM

15.4. Market Size of Polycythemia Vera by Current and Emerging Therapies in the 7MM

15.5. Market Outlook

15.6. Attribute Analysis

15.7. Key Market Forecast Assumptions

15.8. United States Market Size

15.8.1. Total Market Size of Polycythemia Vera in the United States

15.8.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in the United States

15.9. EU-5 Market Size

15.9.1. Total Market size of Polycythemia Vera in Europe

15.9.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in Europe

15.10. Japan

15.10.1. Total Market size of Polycythemia Vera in Japan

15.10.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in Japan

16. Market Drivers

17. Market Barriers

18. Unmet Needs

19. Market Access and Reimbursement

20. KOL Views

21. Appendix

20.1. Bibliography

20.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

List of Table

Table 1: Summary of Polycythemia Vera (PV) Market, and Epidemiology (2019-2032)

Table 2: Thrombotic Complications in Polycythemia Vera (PV)

Table 3: Proposed Modified Criteria for the Diagnosis of Polycythemia Vera

Table 4: Stage 1 and 2 Investigations in Patients With an Absolute Erythrocytosis

Table 5: Recommended Diagnostic Criteria for Polycythemia Vera

Table 6: Management of Polycythemia Vera

Table 7: World Health Organization Diagnostic Criteria for Polycythemia Vera

Table 8: Symptomatic Treatments in Polycythemia Vera

Table 9: Myelosuppressive Agents for the Treatment of Polycythemia Vera

Table 10: European Leukemia Net Criteria for the Definition of Resistance/Intolerance to Hydroxyurea in Patients With PV

Table 11: European Leukemia Net criteria for the Definition of Resistance/Intolerance to Hydroxyurea in Patients With PV

Table 12: Risk Stratification for PV

Table 13: IGW-MRT and ELN Response Criteria for Polycythemia Vera (PV)

Table 14: Total Prevalent Population of PV in the 7MM (2019-2032)

Table 15: Total Prevalent Population of Polycythemia Vera in the US (2019-2032)

Table 16: Prevalent Population of Polycythemia Vera Based on Symptoms in the US (2019-2032)

Table 17: Gender-specific Prevalence of Polycythemia Vera in the US (2019-2032)

Table 18: Prevalence of Polycythemia Vera by Gene Mutation in the US (2019-2032)

Table 19: Prevalence of Polycythemia Vera Based on Risk in the US (2019-2032)

Table 20: Age-specific Diagnosed Prevalence of Polycythemia Vera in the US (2019-2032)

Table 21: Total Prevalent Population of Polycythemia Vera in EU5 (2019-2032)

Table 22: Prevalent Population of Polycythemia Vera Based on Symptoms in EU5 (2019-2032)

Table 23: Gender-specific Prevalence of Polycythemia Vera in Germany (2019-2032)

Table 24: Prevalence of PV by Gene Mutation in EU5 (2019-2032)

Table 25: Prevalence of Polycythemia Vera Based on Risk in EU5 (2019-2032)

Table 26: Age-specific Prevalence of Polycythemia Vera in EU5 (2019-2032)

Table 27: Total Prevalent Population of Polycythemia Vera in Japan (2019-2032)

Table 28: Prevalent Population of Polycythemia Vera Based on Symptoms in Japan (2019-2032)

Table 29: Gender-specific Prevalence of Polycythemia Vera in Japan (2019-2032)

Table 30: Prevalence of PV by Gene Mutation in the Japan (2019-2032)

Table 31: Prevalence of Polycythemia Vera Based on Risk in the Japan (2019-2032)

Table 32: Age-specific Prevalence of Polycythemia Vera in Japan (2019-2032)

Table 33: Comparison of marketed drugs

Table 34: Rusferitide, Clinical Trial Description, 2022

Table 35: Besremi, Clinical Trial Description, 2022

Table 36: Comparison of emerging drugs under development for Polycythemia Vera

Table 37: Rusferitide, Clinical Trial Description, 2022

Table 38: Givinostat, Clinical Trial Description, 2022

Table 39: KRT-232, Clinical Trial Description, 2022

Table 40: Bomedemstat, Clinical Trial Description, 2022

Table 41: Market Size of Polycythemia Vera in the 7MM in USD million (2019-2032)

Table 42: Market Size of Polycythemia Vera by Current Therapies in the 7MM, in USD million (2019-2032)

Table 43: Market Size of Polycythemia Vera by Emerging Therapies in the 7MM, in USD million (2019-2032)

Table 44: Key Market Forecast Assumptions for Rusfertide

Table 45: Key Market Forecast Assumptions for Sapablursen

Table 46: Key Market Forecast Assumptions for Givinostat (1L)

Table 47: Key Market Forecast Assumptions for Givinostat (2L)

Table 48: Key Market Forecast Assumptions for KRT-232

Table 49: Key Market Forecast Assumptions for Bomedemstat

Table 50: Key Market Forecast Assumptions for Itacitinib

Table 51: Key Market Forecast Assumptions for PPMX-T003

Table 52: Market Size of Polycythemia Vera in the US, USD million (2019-2032)

Table 53: Market Size of Polycythemia Vera by Current Therapies in the US, in USD million (2019-2032)

Table 54: Market Size of Polycythemia Vera by Emerging Therapies in the US, in USD million (2019-2032)

Table 55: EU5 Market Size of Polycythemia Vera in USD million (2019-2032)

Table 56: Market Size of Polycythemia Vera by Current Therapies in the EU5, in USD million (2019-2032)

Table 57: Market Size of Polycythemia Vera by Emerging Therapies in the EU5, in USD million (2019-2032)

Table 58: Market Size of Polycythemia Vera in the Japan, USD million (2019-2032)

Table 59: Market Size of Polycythemia Vera by Current Therapies in the Japan, in USD million (2019-2032)

Table 60: Market Size of Polycythemia Vera by Emerging Therapies in the Japan, in USD million (2019-2032)

Table 61: Legislations, Regulations, and Policies for Orphan Drugs by Country

List of Figures

Figure 1: Types of Myeloproliferative Neoplasm (MPN)

Figure 2: Schematic representation of the Epo-mediated signaling pathway

Figure 3: JAK/STAT Pathway  In MPN

Figure 4: Structure of Janus Kinases

Figure 5: Impact of JAK2 V617F Allele

Figure 6: Available treatments for PV

Figure 7: Algorithm for the treatment of Polycythemia Vera.

Figure 8: Current Treatment algorithm for Polycythemia Vera (PV)

Figure 9: Treatment for Low-risk  Polycythemia Vera

Figure 10: Treatment of High-Risk Polycythemia Vera (PV)

Figure 11: Total Prevalent Population of PV in the 7MM (2019-2032)

Figure 12: Total Prevalent Population of Polycythemia Vera in the US (2019-2032)

Figure 13: Prevalent Population of Polycythemia Vera Based on Symptoms in the US (2019-2032)

Figure 14: Gender-specific Prevalence of Polycythemia Vera in the US (2019-2032)

Figure 15: Prevalence of Polycythemia Vera by Gene Mutation in the US (2019-2032)

Figure 16: Prevalence of Polycythemia Vera Based on Risk in the US (2019-2032)

Figure 17: Age-specific Prevalence of Polycythemia Vera in the US (2019-2032)

Figure 18: Total Prevalent Population of Polycythemia Vera in EU5 (2019-2032)

Figure 19: Prevalent Population of Polycythemia Vera Based on Symptoms in EU5 (2019-2032)

Figure 20: Gender-specific Prevalence of Polycythemia Vera in Germany (2019-2032)

Figure 21: Prevalence of PV by Gene Mutation in EU5 (2019-2032)

Figure 22: Prevalence of Polycythemia Vera Based on Risk in EU5 (2019-2032)

Figure 23: Age-specific Prevalence of Polycythemia Vera in EU5 (2019-2032)

Figure 24: Total Prevalent Population of Polycythemia Vera in Japan (2019-2032)

Figure 25: Prevalent Population of Polycythemia Vera Based on Symptoms in Japan (2019-2032)

Figure 26: Gender-specific Prevalence of Polycythemia Vera in Japan (2019-2032)

Figure 27: Prevalence of PV by Gene Mutation in the Japan (2019-2032)

Figure 28: Prevalence of Polycythemia Vera Based on Risk in the Japan (2019-2032)

Figure 29: Age-specific Prevalence of Polycythemia Vera PV in Japan (2019-2032)

Figure 30: Market Size of Polycythemia Vera in the 7MM in USD million (2019-2032)

Figure 31: Market Size of Polycythemia Vera by Current and Emerging Therapies in the 7MM, in USD million (2019-2032)

Figure 32: Market Size of Polycythemia Vera in the US, USD millions (2019-2032)

Figure 33: Market Size of Polycythemia Vera by Current and Emerging Therapies in the US, USD million (2019-2032)

Figure 34: Market Size of Polycythemia Vera in EU5, USD million (2019-2032)

Figure 35: EU5 Market Size of Polycythemia Vera by Current and Emerging Therapies in USD million (2019-2032)

Figure 36: Market Size of Polycythemia Vera in Japan, USD million (2019-2032)

Figure 37: Japan Market Size of Polycythemia Vera by Current and Emerging Therapies, USD million (2019-2032)

Incyte Corporation
Novartis
AOP Orphan Pharmaceuticals and PharmaEssentia
Protagonist Therapeutics
Italfarmaco
Kartos Therapeutics
Imago BioSciences
Ionis Pharmaceutical
Perseus Proteomics

 

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